A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01519089
First received: December 22, 2011
Last updated: August 6, 2015
Last verified: August 2015
  Purpose

The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Drug: CP-690, 550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-term Safety, Tolerability And Efficacy Of 2 Oral Doses Of Cp 690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/or Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.

  • Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

  • Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

  • Number of Participants With Adjudicated Cardiovacular Events [ Time Frame: Baseline to Follow-up ] [ Designated as safety issue: Yes ]
    Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.

  • Number of Participants With Malignancy Events _Week 0 Through Follow-up [ Time Frame: Baseline to Follow-up ] [ Designated as safety issue: Yes ]
    For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.


Secondary Outcome Measures:
  • Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline.

  • Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.

  • Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.

  • Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

  • Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

  • Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

  • Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.

  • Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.

  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.

  • Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

  • Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).

  • Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16 [ Time Frame: Week 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.

  • Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Week 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.

  • Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Week 8, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.

  • Number of Affected Nails [ Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.

  • Itch Severity Item (ISI) Score [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.

  • Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

  • Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score [ Time Frame: Week (W) 16, 28, 52 ] [ Designated as safety issue: No ]
    36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).

  • Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score [ Time Frame: Week 16, 28, 52 ] [ Designated as safety issue: No ]
    36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).

  • Work Limitation Questionnaire (WLQ) [ Time Frame: Baseline (BL), Week (W) 4, 16, 28, 52 ] [ Designated as safety issue: No ]
    WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).

  • Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).

  • Joint Pain Assessment (JPA) [ Time Frame: Baseline, Week 4, 16, 28, 52 ] [ Designated as safety issue: No ]
    The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."

  • Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

  • Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

  • Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).

  • Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).

  • Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).

  • Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.

  • Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    Subjects answered the following question, "Considering the possible effects of the arthritis, how are you feeling today?" The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.

  • Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.

  • Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.

  • Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 ] [ Designated as safety issue: No ]
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.


Enrollment: 95
Study Start Date: March 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-690,550 10 mg BID Drug: CP-690,550
10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
Experimental: CP690,550 5 mg BID Drug: CP-690, 550
5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are 20 years or older and considered to be candidates for systemic or phototherapy.

[Moderate to Severe Plaque Psoriasis]

  • Diagnosed for at least 12 months.
  • Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).

[Psoriatic Arthritis]

  • Diagnosed for at least 6 months.
  • Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
  • Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
  • any uncontrolled significant medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519089

Locations
Japan
JR Sapporo hospital
Sapporo, Hokkaido, Japan, 060-0033
Kobe University Hospital
Chuo-ku, Kobe, Hyogo, Japan, 650-0017
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa, Japan, 920-0293
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan, 252-0392
University of Miyazaki Hospital
Miyazaki-shi, Miyazaki, Japan, 889-1692
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 324-0498
Tokyo Teishin Hospital
Chiyoda-ku, Tokyo, Japan, 102-8798
Tokyo medical university Hachioji medical center
Hachioji, Tokyo, Japan, 193-0998
Kanto Medical Center NTT East Corporation
Shinagawa-ku, Tokyo, Japan, 141-8625
Tokyo Medical University Hospital
Shinjyuku-ku, Tokyo, Japan, 160-0023
Tonami General Hospital
Tonami, Toyama, Japan, 939-1395
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan, 400-8506
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Nissay Hospital
Osaka, Japan, 550-0012
Jikei University Hospital
Tokyo, Japan, 105-8471
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01519089     History of Changes
Other Study ID Numbers: A3921137
Study First Received: December 22, 2011
Results First Received: January 8, 2015
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic
severe
moderate
treatment
safety
efficacy
CP-690
550
Plaque psoriasis
Psoriasis Vulgaris
Psoriatic Arthritis
tofacitinib
Xeljanz

Additional relevant MeSH terms:
Arthritis, Psoriatic
Psoriasis
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 31, 2015